|
Device | Reply SR and Reply DR Pacemakers |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S124 |
Date Received | 02/10/2020 |
Decision Date | 03/06/2020 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implement sterilization cycle MicroPort01 at Steris SpA contactor. |